Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older, of any gender
• People who have been newly diagnosed with marginal zone lymphoma (a type of slow-growing blood cancer) confirmed by a tissue biopsy, including types that affect organs outside lymph nodes, lymph nodes themselves, or the spleen
• People who have at least one measurable area of disease — either a lymph node larger than 1.5 cm or a growth in another area larger than 1.0 cm
• People with a general health and activity level score of 2 or lower on a standard medical scale (meaning able to care for oneself but may not be able to do heavy physical work)
• People with an expected survival of at least 12 weeks
• People who have never received any cancer treatment before
• People whose bone marrow and major organs (liver, kidneys, etc.) are functioning well enough to meet specific blood and lab test thresholds, including:
  • A haemoglobin level of at least 90 g/L (without recent blood transfusion or medication to boost it)
  • A neutrophil (infection-fighting white blood cell) count of at least 1.5 × 10⁹/L
  • A platelet count of at least 100 × 10⁹/L
  • Liver enzyme and bilirubin levels within acceptable ranges
  • Kidney function within acceptable ranges
  • Blood clotting measurements within acceptable ranges
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting the trial drug, and must agree to use effective contraception during the trial and for 1 year after the last dose
• Male participants whose partners could become pregnant must either have had a sterilisation procedure or agree to use effective contraception during the trial and for 1 year after the last dose
• People who are willing to participate, have signed a consent form, and are able to attend follow-up appointments

Who may not be able to join:

• People who have previously received any treatment that targets a pathway in the body called PI3K
• People who have had another serious (invasive) cancer that is either still active or was treated less than 3 years ago
• People whose lymphoma has spread to the brain or the lining around the brain
• People with a known allergy to any of the drugs used in this trial
• People who have taken part in another clinical drug trial within the 4 weeks before this study begins
• Women who are pregnant or breastfeeding
• People who currently have an active infection (not including fever that is related to the lymphoma itself)
• People who have difficulty swallowing, chronic diarrhoea, or a bowel obstruction that would prevent them from taking oral medication
• People with a history of psychotropic drug misuse they are unable to stop, or who have a mental health condition that would affect participation
• People with high blood pressure that is not well controlled (top number 150 mmHg or higher, or bottom number 100 mmHg or higher)
• People with significant heart problems, including moderate-to-severe heart muscle issues, certain abnormal heart rhythms, or moderate-to-severe heart failure
• People with active lung inflammation or chronic lung disease causing significantly reduced lung function, or a history of lung inflammation caused by COVID-19
• People with severe liver disease, including advanced cirrhosis or clinically significant liver conditions; people with active hepatitis B (confirmed by DNA levels above specified thresholds) or active hepatitis C (confirmed by RNA levels above specified thresholds)
• People with kidney failure requiring dialysis
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated draining
• People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
• People whose urine tests show a significant amount of protein, confirmed by a 24-hour urine test showing more than 1.0 g of protein
• People with a history of immune system deficiency, including a positive HIV test, other inherited or acquired immune conditions, or a history of organ transplantation
• People who, in the treating doctor's judgement, have other health conditions that could pose a serious risk to their safety or prevent them from completing the study

Important: Always verify eligibility with the trial site directly before applying.